NCT05268198

Brief Summary

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of APR002 in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for early_phase_1 covid19

Timeline
Completed

Started Mar 2023

Shorter than P25 for early_phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
Last Updated

August 2, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

February 17, 2022

Last Update Submit

August 1, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of APR002 in healthy subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria

    Safety assessments will include evaluation of incidence of treatment-emergent adverse events (AEs) according to CTCAE v5.0 criteria, including vital signs, resting electrocardiogram (ECG) parameters, standard hematology, chemistry, urinalysis and other tests

    Screening up to Day 14

Secondary Outcomes (5)

  • Pharmacokinetics of APR002 in healthy subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose

    Day 1 to Day 3

  • Pharmacokinetics of APR002 in healthy subjects as assessed by time to maximum concentration (Tmax) towards determination of the optimal pharmacokinetic dose

    Day 1 to Day 3

  • Pharmacokinetics of APR002 in healthy subjects as assessed by plasma exposure (AUC0-t, AUC0-inf) determination of the optimal pharmacokinetic dose

    Day 1 to Day 3

  • Pharmacokinetics of APR002 in healthy subjects as assessed by terminal elimination half life (t1/2) determination of the optimal pharmacokinetic dose

    Day 1 to Day 3

  • Pharmacokinetics of APR002 in healthy subjects as assessed by apparent volume of distribution during the terminal elimination phase after inhalation (extravascular) administration for determination of the optimal pharmacokinetic dose

    Day 1 to Day 3

Study Arms (2)

Intervention/Treatment

EXPERIMENTAL

Single dose, oral inhalation (nebuliser solution)

Drug: APR002

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

APR002DRUG

Active Investigational Product

Also known as: TLR7 agonist
Intervention/Treatment
PlaceboDRUG

Placebo

Also known as: 0.9% Sodium Chloride; Saline
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men or women aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
  • Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method
  • Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months
  • Have a body mass index (BMI) between 18 and 32 kg/m2 and weigh at least 45 kg.

You may not qualify if:

  • History or presence of clinically significant medical (e.g., chronic obstructive pulmonary disease, asthma, COVID-19, etc.) or psychiatric condition or disease
  • Abnormal vital signs, after minutes rest, defined as any of the following (SBP \> 140 mmHg, Diastolic blood pressure (DBP) \> 90 mmHg, Heart rate \< 40 or \> 99 beats per minute)
  • Prolonged QTcF \> 450 ms or family history of long QT syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

COVID-19

Interventions

APR002Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Aaron Weitzman

    Global Health Drug Discovery Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 7, 2022

Study Start

March 20, 2023

Primary Completion

June 29, 2023

Study Completion

July 27, 2023

Last Updated

August 2, 2023

Record last verified: 2023-08

Locations

AU(1)